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Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings (FRAILTOOLS)

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ClinicalTrials.gov Identifier: NCT02637518
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Hospital Universitario Getafe

Brief Summary:
There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations, surgical and non surgical complications, length of stay, death, incident disability, etc.) in emergency departments, surgical patients, and inpatients with cardiovascular disease. The studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnosis or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk of frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represents around 40-50% of people older than 65, and 60-70% of people older than 75. Once determining the best tools of screening and diagnosis in different settings of care, investigators will research conclusions of these people wherever the level of care they need and currently use. The benefit will spend to the Health System and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.

Condition or disease Intervention/treatment
Syndrome Other: Assessment of frailty tools in elderly people

Detailed Description:

Quality assurance plan:

According to the European's Commission guidelines, the procedure for quality control focuses on the deliverables revision and in the quality of each procedure. The deliverables will be sent to the Administrative committee. The administrative Committee, composed by the Project's Promoter and its associates, will assume the role as a quality manager. It includes the following tasks:

Making sure of the monitoring of all of the changes in documentation. Making sure the activity's coordination and reports are completed according to an adequate quality and in an appropriate manner.

Reviewing the contract deliverables. Monitoring and auditing the project's activities according to plan, making the specific revisions of the contractual deliverables, directed to the achievement of the established objectives.

The electronic Case Report Form (eCRF) has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none identification card number will be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.

Plan for missing data to address situations where variables are reported as missing:

The investigators will check the missing data in each eCRF and source documents.

Statistical analysis:

Investigator will assess the associations of each scale with the outcome for each setting and outcome through logistic regressions. First, investigators will compute the classification performance (sensitivity, specificity, Receptors Operational Curve (ROC), Area Under the Curve (AUC), predictive values, likelihood ratios) for each model. Second, investigators will study the feasibility of the models taking into account the time needed for the scale and the percentage of patients that can be assessed per case. Investigators will evaluate the sensitivity to change of the scales and the covariance of the scales with other measures as the SPPB through a mixed linear model.

Sample Size: Participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample will be of 1.940 subjects. Each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.


Study Type : Observational
Estimated Enrollment : 1940 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comprehensive Validation of Frailty Assessment Tools to Screen and Diagnose Frailty in Different Clinical and Social Settings and to Provide Instruments for Integrated Care in Older Adults.
Study Start Date : May 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Group/Cohort Intervention/treatment
Hospital Universitario de Getafe

Assessment of frailty tools in elderly people

The Geriatric Department attends patients:

1800/year - acute unit. 800/year - Orthogeriatrics and Interconsultation Unit. 300/year - Day Hospital. 4000/year - Outpatient office. 1200/year - Domiciliary Care.

Other: Assessment of frailty tools in elderly people
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
Diabetes Frail Ltd.
Assessment of frailty tools in elderly people Has significant experience in managing research studies in older people.
Other: Assessment of frailty tools in elderly people
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
Università Cattólica del Sacro Cuore

Assessment of frailty tools in elderly people

The Geriatric Unit is compounded by:

24 beds of Acute Care Ward 46 beds of Intensive Rehabilitation Unit 20 beds of Day Hospital Outpatient clinic

Other: Assessment of frailty tools in elderly people
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
Gérontopole de Toulouse

Assessment of frailty tools in elderly people

The Geriatric Unit is compounded by:

5 Acute Care Units - 100 beds. 3 Rehabilitation Unit - 75 beds. Long term care Unit - 140 beds. 2 Day Hospitals Outpatient Clinic

Other: Assessment of frailty tools in elderly people
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
Jagiellonian University Medical College
Assessment of frailty tools in elderly people The Department of Internal Medicine and Gerontology is the largest centre in Poland limited to the Geriatric market.
Other: Assessment of frailty tools in elderly people
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)



Primary Outcome Measures :
  1. Mortality [ Time Frame: 18 months ]
    data obtained from the official registration of the country of the corresponding partner. When not available, other methods will be used (asking to a proxy, calls to nursing homes, medical registries, etc.).

  2. Functional disability [ Time Frame: 18 months ]
    Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).

  3. Disability to perform IADL [ Time Frame: 18 months ]
    Defined as a loss of at least one point in the Lawton Index

  4. Disability to perform BADL [ Time Frame: 18 months ]
    Defined as a loss of at least one point in the Barthel Index.

  5. Falls [ Time Frame: 18 months ]
    Data will be collected by the participant's verbal recall (self-assessed) and will be registered in the electronic Case Report Form (eCRF).

  6. Incident cognitive impairment [ Time Frame: 18 months ]
    Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).


Secondary Outcome Measures :
  1. Frailty classification performance [ Time Frame: 18 months ]
    Performance of the instruments by clinical setting: six frailty assessment tools will be used in four different levels of care. The performance of each scale in the classification of frailty will be established.

  2. Tool feasibility [ Time Frame: 18 months ]
    Composed by two main conditions: the percentage of people that are assessed by each tool in each setting (adequacy) and the time for carrying out the the tool assessment.

  3. Sensitivity to change in frailty status [ Time Frame: 18 months ]
    Evaluate the changes in the assessment level of patients observed at 12 and 18 months with each of the tools and their correlations with the changes observed in the patient´s functional status.

  4. Qualification as a screening and/or diagnosis tool [ Time Frame: 18 months ]
    Evaluate the utility of each scale as a frailty detection method for screening or diagnosis, using pre-established criteria.



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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People older than 75 years old will be included, recruited from different clinical settings such as clinical (hospital or primary care) and social (nursing homes).
Criteria

Inclusion Criteria:

  • People older than 75 years old, who sign the informed consent after accepting their participation.

Exclusion Criteria:

  • General exclusion criteria will be an MMSE score less than 20 points or having a terminal illness (life expectancy < 6 months).
  • Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient
  • Geriatric Consultation) and primary care will have additional exclusion criteria: dependency in more than 2 Instrumental Activities of Daily Living (IADL) in women (Lawton < 6), and in more than 3 IADL in men (Lawton < 5).
  • Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637518


Contacts
Contact: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD +34 916839360 ext 2760 leocadio.rodriguez@salud.madrid.org
Contact: MARTA CHECA LOPEZ, MD +34 916839360 ext 2760 marta.checa@salud.madrid.org

Locations
Spain
Hospital Universitario de Getafe Recruiting
Getafe, Madrid, Spain, 28905
Contact: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD    +34916839360 ext 2760    leocadio.rodriguez@salud.madrid.org   
Contact: MARTA CHECA LOPEZ, MD    +34916839360 ext 2760    marta.checa@salud.madrid.org   
Sponsors and Collaborators
Hospital Universitario Getafe
European Commission
Investigators
Principal Investigator: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD HOSPITAL UNIVERSITARIO DE GETAFE

Publications:
Responsible Party: Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT02637518     History of Changes
Other Study ID Numbers: 662887
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Hospital Universitario Getafe:
Frailty
Frailty screening tools
Clinical settings
Social settings
Geriatrics
Functional autonomy
Disability